System and method for graphically configuring leads

ABSTRACT

Systems and methods are provided for graphically configuring leads for a medical device. According to one aspect, the system generally comprises a medical device and a processing device, such as a programmer or computer, adapted to be in communication with the medical device. The medical device has at least one lead with at least one electrode in a configuration that can be changed using the processing device. The processing device provides a graphical display of the configuration, including a representative image of a proposed electrical signal to be applied by the medical device between the at least one electrode of the medical device and at least one other electrode before the medical device applies the electrical signal between the at least one electrode and the at least one other electrode. In one embodiment, the graphical display graphically represents the lead(s), the electrode(s), a pulse polarity, and a vector.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.09/738,400, filed on Dec. 15, 2000, the specification of which isincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates generally to the field of medical devices, andmore particularly to systems and methods for graphically representingconfigurations for medical devices.

BACKGROUND

Medical devices, including cardiac stimulus devices such as implantablecardiac pacemakers and implantable cardioverter defibrillators (ICDs),are surgically implanted within a patient and have one or moreelectrical leads that conduct signals to and receive signals from thepatient's heart. Each electrical lead has at least one electrode.Electrode types include ring, tip, and coil electrodes. Tip electrodesare positioned at the tip of the lead, and ring electrodes are bandspositioned along the length of the lead. Coil electrodes are exposedconductor coils positioned along the lead, and are often used as part ofa defibrillator to disperse a strong signal throughout the heart.Several of these electrode types may be placed on a single lead, andseveral of these leads may be placed in or around an organ such as theheart. Additionally, each of the electrodes may be configured totransmit or conduct a signal or pulse, or to receive or sense a signal.As such, the lead(s) with the electrode(s) are in a configuration withrespect to their position and their electrical character or nature. Theelectrical character of the electrode(s) may be changed, and one methodfor changing the configuration is through programming.

A programming device or programmer communicates with the device. Onecommunication method uses a telemetry link that enables commands anddata to be non-invasively transmitted and received between theprogrammer and the device. During a programming operation, a user setsprogrammable parameters, including those parameters that relate to theconfiguration of the electrode(s), to values that cause the medicaldevice to work in an optimum way for a particular patient. There are anumber of reasons for which it is desirable to change the configuration.One reason is that the appearance of an electrogram (ECG, EGM) and thedetection of intrinsic heart signals can be improved by changing thesensing configuration for a particular patient. Another reason is thatthe anode usually drifts slightly over time in its threshold voltagesand thus requires more power to deliver the same pacing pulse.Reprogramming or reconfiguring the pacemaker to switch over and pacefrom the cathode rather than the anode can reduce the powerrequirements. Yet another reason is that the pacing electrode may havebeen placed near or on top of a diaphragm nerve such that the patienthiccups at each pacing pulse. Changing the pacing pulse resolves thissituation. The list of reasons given above are nonexclusive as oneskilled in the art would recognize that other reasons exist.

As medical devices provide more leads, electrodes per lead, andprogramming parameters for the leads, programming a configuration tendsto become more complicated and confusing. Due to discrepancies in theterminology and procedures used in the medical field between doctors,clinical engineers or other users, there may be problems in connecting atextual term such as “unipolar” or “bipolar” with the placement of theleads and the actual pacing and sensing vectors between the electrodeson the leads.

Therefore, there is a need in the art to provide a system and method forgraphically configuring leads of medical devices.

SUMMARY OF THE INVENTION

The present subject matter provides systems and methods to address theaforementioned problems by graphically displaying configurations formedical devices. These systems and methods provide a programmerinterface that graphically represents, illustrates or displays thelead(s), the electrode(s) on the lead(s), and the associated electricalvectors between the electrode(s) of the medical device. In a cardiacstimulation device such as a pacemaker or defibrillator, for example,the graphical representation may resemble the placement of leads insideand outside of the heart. Thus, the user visualizes the presentconfiguration of the medical device through a graphical representation.In one embodiment, the graphical image illustrates how newly programmedsettings would work before these changed settings are accepted andprogrammed into the medical device.

In one embodiment, the system generally comprises a medical device and aprocessing device, such as a programmer for example. The medical devicehas at least one lead, and each lead has at least one electrode. Thelead(s) and electrode(s) are programmed, arranged or otherwiseconfigured in an attempt to optimize the operation of the medical devicefor a particular patient. The programmer communicates with the medicaldevice. The programmer provides a graphical display of the configurationfor the medical device.

In one embodiment, the display includes an electrode representation anda lead representation. In other embodiments, the electroderepresentation includes but is not limited to one or more of thefollowing representations: an electrode type representation, anelectrode quantity representation, and an electrode positionrepresentation. Also, the lead representation includes but is notlimited to a lead position representation for each lead. In anembodiment in which the medical device is a cardiac stimulus device suchas a pacemaker or defibrillator, the lead representation includes agraphical representation or illustration of the arrangement of thelead(s) and the electrode(s) provided thereon as arranged within aheart. Further, in one embodiment, the graphical display represents apulse polarity, an electrical vector between electrodes such as a pacevector, a sense vector, a defibrillation vector, or a vector for othertypes of energy delivery. Additionally, in one embodiment, the displayincludes a color scheme to distinguish the elements represented in thedisplay.

Since a user is able to change the programmable parameters of medicaldevices, including those associated with configuring electrodes, oneembodiment includes displaying both the current or present settings andthe proposed or changed settings of the configuration. In oneembodiment, the proposed or changed settings are entered by the userduring the programming of the device, and the current or presentsettings are retrieved from a memory such as the memory of theprogrammer. A user reviews both settings to verify that the changedsettings are desirable before accepting them.

The present subject matter provides a programmer device that generallycomprises circuitry for communicating with a medical device havinglead(s) with electrode(s) in a configuration, and a display forgraphically representing the configuration. In one embodiment, thedisplay of the programmer device includes both a lead representation andan electrode representation. In various embodiments, the leadrepresentation includes a lead position representation; and theelectrode representation includes one or more of the followingrepresentations: an electrode position representation, a pulse polarityrepresentation, and an electrical vector representation.

The present subject matter also provides a computer-readable mediumencoded with a software program for providing a graphical display of alead configuration for an implantable medical device. In one embodiment,for example, this software program operates in a memory of a programmerfor a medical device. In other embodiments, the software programoperates in a memory of another processing device, such as a computer.The software program executes the following: receiving information abouta lead configuration, and graphically representing the leadconfiguration. In other embodiments, graphically representing theconfiguration includes graphically displaying one or more of thefollowing representations: a lead representation, an electroderepresentation, a pulse polarity representation, and an electricalvector representation. These representations graphically illustrate ordisplay the physical lead configuration that includes, but is notlimited to, one or more of the electrode quantity, the physicalarrangement of the electrodes, the electrode type, the pulse polarityand the electrical vectors between the electrodes.

The present subject matter also provides a method that generallycomprises: receiving information for a medical device having at leastone lead with at least one electrode in a configuration, and presentinga graphical representation of the configuration. In one embodiment, theinformation is retrieved from a memory, such as that stored in a patientdata section of the programmer. In another embodiment, presenting agraphical representation of the configuration information includes, butis not limited to, graphically representing one or more of thefollowing: an arrangement of the lead(s) in a heart, an electrode type,a pulse polarity, an electrical vector between electrodes. In oneembodiment, the method further comprises programming a change in theconfiguration. In one embodiment, presenting a graphical representationof the configuration information includes presenting both currentsettings and changed settings for the medical device.

These and other aspects, features, embodiments and advantages of theinvention will become apparent from the following description of thepreferred embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a system according to one embodiment.

FIG. 2 is a block diagram of one embodiment of the system of FIG. 1.

FIG. 3 is an illustration of a lead having a tip electrode and coilelectrodes.

FIG. 4 is an illustration of a lead having a tip electrode and ringelectrodes.

FIG. 5 is a first example of a graphical display illustrating aconfiguration for a medical device.

FIG. 6 is a second example of a graphical display illustrating aconfiguration for a medical device.

FIG. 7 is a flow diagram for a software program according to oneembodiment.

FIG. 8 is a flow diagram for a method according to one embodiment.

FIGS. 9-14 illustrate pacing vector examples for a left ventricularlead.

FIGS. 15-17 illustrate sensing vector examples for a left ventricularlead.

FIGS. 18-19 illustrate pacing vector examples for an atrial lead.

FIGS. 20-21 illustrate sensing vector examples for an atrial lead.

FIGS. 22-23 illustrate defibrillation vector examples.

FIGS. 24-25 illustrate pacing vector examples for a right ventricularlead.

FIGS. 26-27 illustrate sensing vector examples for a right ventricularlead.

DETAILED DESCRIPTION

In the following detailed description, references are made to theaccompanying drawings that illustrate specific embodiments in which theinvention may be practiced. Changes in the electrical, mechanical,structural, logical or programming designs may be made to theembodiments without departing from the spirit and scope of the presentinvention. The following detailed description is, therefore, not to betaken in a limiting sense and the scope of the present invention isdefined by the appended claims and their equivalents.

The present subject matter addresses the aforementioned problems, andaspects of the present subject matter are shown and described herein.The present subject matter provides an interface for graphicallydisplaying the configuration of medical devices. One embodimentgraphically represents, illustrates or displays the lead(s), theelectrode(s), the pulse polarity, and the electrical vectors associatedwith the configuration.

Various aspects of the present subject matter are presented below. Oneaspect is a system such as a cardiac rhythm management system. Anotheraspect is a processing device, such as a programmer or computer, foundwithin the system. Other aspects include a software program thatprovides the graphical interface for viewing and changing theconfiguration, and a method of providing an interface for configuring amedical device. The software program is adapted to reside in the memoryof a computer, such as a programmer, a personal computer or otherprocessing device and to be executed by a processor.

FIG. 1 provides an illustration of a cardiac rhythm management system 10according to the present subject matter. The system 10 generallycomprises a medical device 12 and a programmer 14. The medical device 12includes but is not limited to cardiac stimulation devices such aspacemakers and defibrillators. The medical device 12 has an electrodesystem 16 comprised of at least one lead and at least one electrode 24for each lead. FIG. 1 shows an example in which there are three leads18, 20 and 22. The leads 18, 20 and 22 are inserted into a patient'sheart 26, and transmit electrical signals or pulses to the heart 26 andreceive or sense electrical signals from the heart 26. The lead(s) 18,20 and 22 and electrode(s) 24 are arranged, programmed and/or otherwiseconfigured to provide the medical device 12 with a desired configurationin an attempt to optimize the operation of the medical device 12 for aparticular patient.

The leads 18, 20 and 22 and the electrodes 24 on the leads arephysically arranged with respect to the heart 26 in a fashion thatenables the electrodes 24 to properly transmit pulses and sense signalsfrom the heart 26. As there may be a number of leads 18, 20 and 22 and anumber of electrodes 24 per lead, the configuration can be programmed touse a particular electrode or electrodes to provide the pulse and alsoto use particular electrodes to sense the electrical activity of theheart. As such, the lead configuration information for a medical device12 includes but is not limited to one or more of the lead quantity, thephysical arrangement of the leads 18, 20 and 22, the electrode quantity,the physical arrangement of the electrodes 24, the electrode type, thepulse polarity, and the electrical vectors between the electrodes.

FIGS. 1 and 2 show the processing device 14, such as a computer orprogrammer for example, coupled or otherwise in communication with themedical device 12. In one embodiment, the programmer 14 is coupledthrough complementary communication circuits 28 that provide a radiofrequency telemetry channel 30 between the programmer 14 and the device12. In another embodiment, the medical device 12 and programmer 14communicate with each other using inductive coils. The programmer 14 hasa graphical display 32 of the configuration for the medical device 12.In one embodiment, the graphical display 32 is a screen display 34 thatforms an integral part of the programmer 14, computer or otherprocessing device. However, the graphical display is not so limited. Inone embodiment, the screen display 34 is an electronic display such as aCRT monitor that projects the image on a screen or a liquid crystaldisplay LCD, for example. In other embodiments, the graphical display 32includes other means for graphically displaying the configuration. Theseother means include, but are not limited to, printing out the graphicaldisplay 32 on a printer, and projecting the graphical display of theconfiguration on a device in communication with the programmer such as,for example, a local peripheral device, a remote device, or a devicenetworked to the programmer. In one embodiment, a personal computer orother processing device, retrieves configuration information, definedabove to include but not be limited to the quantity and physicalarrangement of the leads 18, 20 and 22, the quantity and physicalarrangement of the electrodes 24, the electrode type, the pulsepolarity, and the electrical vectors between the electrodes. Thecomputer then transmits the data remotely, over telecommunication lines,for example, to a clinic where it is displayed on a monitor or printedas the graphical display 32. One embodiment allows for communicationover the Internet global computer network or world wide web. Oneembodiment of the processing device displays the graphical display 32locally.

A physical illustration of a first lead 20 is provided in FIG. 3 and aphysical illustration of a second lead 22 is provided in FIG. 4.Although not drawn to scale, these two illustrations are provided asexamples of leads that correspond with the illustrated graphicaldisplays 32 of FIGS. 5 and 6 discussed in more detail below. In no wayshould the inclusion of this example throughout this specification beread as limiting. The first lead 20 shown in FIG. 3 includes a tipelectrode 36, a first coil electrode 38, and a second coil electrode 40.As generally shown in FIG. 1, this lead 20 may be inserted into theright atrium 42 and ventricle 44 so that the first coil electrode 38 ispositioned in the right atrium 42 and the second coil electrode 40 ispositioned in the right ventricle 44. The second lead 22 shown in FIG. 4includes a tip electrode 36, a first ring electrode 46, and second ringelectrode 48. Also as generally shown in FIG. 1, this second lead 22 maybe inserted through the left atrium 50 and into the left ventricle 52(coronary sinus implant) so that the first and second ring electrodes 46and 48 are positioned in the left ventricle 52 and form a dual electrodeconfiguration for the left ventricle 52.

Graphical displays 32 for a first and second configuration 54 and 56 ofa particular medical device 12 are illustrated in FIGS. 5 and 6. Thesedisplays 32 illustrate the leads 20 and 22 that are shown in FIGS. 3 and4 and that are generally positioned as illustrated in FIG. 1. Each image58 and 60 in the illustrated graphical display 32 contains three lines,wherein each line provides a lead representation. The first linerepresents the first lead 20 of FIG. 3 extending through the rightatrium 42 and ventricle 44 as described above and as generallyillustrated in FIG. 1. The second line represents the second lead 22 ofFIG. 4 extending into the left ventricle 52 as illustrated in FIG. 1. Athird line represents an atrial lead 18 extending into the right atrium42 as illustrated in FIG. 1. These figures illustrate one example of aconfiguration. Other leads or lead positions are displayed for otherspecific configurations of a medical device 12. In the illustratedembodiment, an electrode representation is provided by the bands 38 and40 on the first lead 20 and the dots 36 and 46 on the second lead 22.The bands 38 and 40, represented by thicker lines in these monochromaticfigures, represent coil electrodes 38 and 40 and their respectivepositions on the first lead 20, and the dots represent tip and ringelectrodes 36 and 46 and their respective positions on the second lead22.

Additionally, in one embodiment, a color scheme is used to distinguishor otherwise represent the elements contained in the display. Forexample, in one embodiment, the leads are represented by colored linessuch as blue for the right atrium lead 18, purple for the rightventricle lead 20, and orange for the left ventricle lead 22.Additionally, the coil electrodes 38 and 40 are represented as blackbands on the purple lead 20, and the tip and ring electrodes 36 and 46are represented as black dots on the orange second lead 22. Although theexact color scheme used may vary, the use of the color scheme todistinguish the elements contained in the display enhances the abilityof the graphical display 32 to quickly and easily convey information aspart of the interface of the programmer 14. In one embodiment, the bands38 and 40 may be represented by a color distinction, such as black on acolored lead line, rather than by a thicker line. Further, in oneembodiment, selected elements in the display are represented as blinkingelements.

As is understood from FIGS. 5 and 6, the lead representation includesbut is not limited to a lead position or arrangement representation foreach lead 18, 20 and 22. That is, the graphical display 32 provides anindication or representation of how the leads 18, 20 and 22 are arrangedin the patient. And for a cardiac stimulus device such as a pacemaker ora defibrillator, the lead representation may include a graphicalrepresentation of the arrangement of the lead(s) 18, 20 and 22 andelectrode(s) 24 as they are positioned within a heart 26. This is shownby comparing the arrangement of the graphically illustrated leads 18, 20and 22 shown in the displays of FIGS. 5 and 6 with the physicalarrangement of the leads 18, 20 and 22 in the heart 26 of FIG. 1 and thephysical illustration of the leads themselves in FIGS. 3 and 4. Thearrangement of the illustrated leads 18, 20 and 22 corresponds to thearrangement of the physical leads 18, 20 and 22 in the heart 26. Theaccuracy in correlating the physical position or arrangement of theleads with a lead position representation varies among embodiments. Inone embodiment, for example, any lead that is inserted in or around theleft ventricle may be represented by the lead 22 that is illustrated inFIG. 5. Another embodiment provides a closer correlation between theactual physical arrangement of the lead and the lead positionrepresentation such that the lead 22 illustrated in FIG. 5 onlyrepresents a physical lead that has been positioned into a mid-lateralposition of the left ventricle, and another lead, that is notillustrated, represents a physical lead positioned elsewhere in oraround the left ventricle.

Also, as is understood from FIGS. 5 and 6, this particular embodiment ofthe electrode representation provides an electrode quantityrepresentation for each lead 18, and 22, an electrode positionrepresentation for each electrode 24, and an electrode typerepresentation for each electrode 24.

With respect to the electrode quantity representation, FIG. 5 shows thatthe medical device 12 has a total of four electrodes 38, 40, 46 and 36with two on the first lead 20 and two on the second lead 22, and FIG. 6shows that the medical device has a total of five electrodes 38, 40, 46,48 and 36 with two on the first lead 20 and three on the second lead 22.

With respect to the electrode position representation, FIG. 5 shows thatthe first lead 20 has an electrode 38 in the right atrium 42 and anotherelectrode 40 in the right ventricle 44, and that the second lead 22 hasan electrode 36 on its distal end and another electrode 46 along itslength that, as illustrated, together form a dual electrodeconfiguration for the left ventricle 52. This dual electrodeconfiguration also is provided in the *Electrode Config row 62 of thetable at the top of FIG. 5. Similarly, it is seen in FIG. 6 that thefirst lead 20 has an electrode 38 in the right atrium 42 and anotherelectrode 40 in the right ventricle 44, and that the second lead 22 hasan electrode 36 on its distal end and two other electrodes 46 and 48along its length that, as illustrated, together form a triple electrodeconfiguration for the left ventricle 52. This triple electrodeconfiguration also is provided in the *Electrode Config row 62 of thetable at the top of FIG. 6. The accuracy in correlating the physicalposition of the electrodes with an electrode representation varies amongembodiments.

With respect to the electrode type representation, FIG. 5 shows that thetwo electrodes illustrated by the two bands 38 and 40 on the first lead20 indicate that those electrodes are coils, that the electrodeillustrated by the dot 36 at the distal end of the second lead 22 is atip electrode, and that the electrode illustrated by the other dot 46along the length of the second lead is a ring electrode. FIG. 6 showsthat the two electrodes illustrated by the two bands 38 and 40 on thefirst lead 20 indicate that those electrodes are coils, that theelectrode illustrated by the dot 36 at the distal end of the second leadis a tip electrode, and that the two electrodes illustrated by the othertwo dots 46 and 48 along the length of the second lead 22 are ringelectrodes. It is further noted that, as indicated by the lineconnecting these other two dots, these two ring electrodes 46 and 48 areelectrically connected to form one electrode. In one embodiment, a colorscheme is used to represent an electrode type either in addition to orin place of using shapes and electrode positions to determine theelectrode type.

One embodiment of an electrode representation is provided by theabove-described electrode quantity representation, electrode positionrepresentation, and electrode type representation for each electrode.The electrode representation is not so limited to the particulars ofthat embodiment, however. Other embodiments use other images and iconsto represent electrode quantity, electrode position, lead position, andelectrode type.

Further, as is understood from FIGS. 5 and 6, the graphical display 32may represent electrical vectors between electrodes, such as theillustrated pace vectors 66 and sense vectors 68, and a pace polarity.First, each of the illustrated screen displays includes twoillustrations 58 and 60. The first illustration provides a pace vectorillustration 58, and the second illustration provides a sense vectorillustration 60. Specifically, for the examples of the graphicaldisplays 32 shown in FIGS. 5 and 6, the pace and sense vectorillustrations 58 and 60 are for the left ventricle 52.

The vector representations are not limited to the illustrated pacevectors 66 and sense vectors 68, but rather include vectors for othertypes of energy delivery such as defibrillation vectors. One example ofa defibrillation vector is “Distal Spring to Proximal Spring”, i.e.distal coil electrode 40 to proximal coil electrode 38. Another exampleof a defibrillation vector is “Distal Spring to Can (PG)”, in which themedical device 12 is referred to as a pulse generator, i.e. PG, or can.In this example, the can forms one of the electrodes and the distal coilelectrode 40 forms the other electrode for the defibrillation vector. Asimplified bradycardia device, for example, also paces from the distalelectrode back to the can.

Referring now to the L VPace illustration 58 of FIG. 5, a pace vector 66indicates that the pace pulse is being transmitted between the coil 40in the right ventricle 44 and the ring electrode 46 in the leftventricle 52, and the polarity of the pace pulse is represented by theplus (+) and minus (−) signs next to the vector 66. Therefore, the paceconfiguration is said to be “Ring-to-Coil” as indicated in the “*Pace”row 70 of the table on the top of FIG. 5, which means that the Ringelectrode 46 paces against the coil electrode 40. Similarly, referringnow to the LV Pace illustration of FIG. 6, a pace vector 66 indicatesthat the pace pulse is being transmitted between the coil 40 in theright ventricle 44 and the ring electrodes 46 and 48 and tip electrode36 in the left ventricle 52. The polarity of the pace pulse, asrepresented by the plus (+) and minus (−) signs next to the vector,indicates that the pace configuration is “T+R to Coil”, as provided inthe “*Pace” row 70, which means that the Tip 36 and Ring 46 and 48together pace against the Coil 40.

Referring now to the LV Sense illustration 60 of FIG. 5, a sense vector68 indicates that electrical signals from the heart 26 are beingdetected between the coil 40 in the right ventricle 44 and the tipelectrode 36 in the left ventricle 52. Therefore, the senseconfiguration is said to be “Tip to Coil” as provided in the “*Sense”row 72 of the table on the top of FIG. 5. Similarly, referring now tothe LV Sense illustration 60 of FIG. 6, a sense vector 68 indicates thatelectrical signals from the heart 26 are being detected between the tip36 and the two ring conductors 46 and 48. Therefore, the senseconfiguration is said to be “Tip to Ring” as provided in the “*Sense”row 72.

One embodiment has been described above for the pace polarityrepresentation (i.e. the plus and minus signs), the pace vectorrepresentation 58, and the sense vector representation 60. Therepresentations are not so limited to the particulars of thatembodiment, however. Other embodiments use other images and icons torepresent pace polarity, and vector(s).

In one embodiment, the programmer 14 is used to change the programmableparameters of the medical device 12, including those parameters forconfiguring the electrode(s) of the medical device 12. As such, theprogrammer 14 provides means for changing a configuration, and a user ofthe programmer performs the step of programming a change in theconfiguration. In one embodiment, the graphical display 32 representsthe current or present settings 74 of the configuration which werepreviously stored in a memory such as the memory of the programmer 14.And in another embodiment, the graphical display 32 represents thechanged or proposed changed settings 76. Thus a user can review bothsettings to verify that the changed settings 76 are desirable beforeaccepting them.

FIG. 2 illustrates a block diagram of the system shown in FIG. 1. In oneembodiment, the medical device 12 is a programmable microprocessor-basedsystem that generally comprises a processor 78, a memory 80, acommunication circuit 28, pulse/sense circuitry 82, and a power supplyor battery 84. The processor 78 and memory 80 are used to control theprocess steps conducted by the medical device 12. For example, theprocessor 78 is programmed to detect a sensed condition or response in apatient's heart 26 and to respond appropriately. The memory 80 containsparameters for various pacing and sensing modes, and further stores dataconcerning the condition of the heart 26 as derived from the receivedcardiac signals. The medical device 12 uses the pulse/sense circuitry 82to interface with the leads, i.e. to transmit the signal to the heart 26and to receive the signal from the heart 26 through these leads. Thecommunication circuit 28 allows the medical device 12 and the programmer14 to communicate with each other.

Another aspect of the present subject matter provides a device 14, suchas a programmer, personal computer or other processing device, which isalso shown in the block diagram of FIG. 2. The processing device 14generally comprises a processor 86, a circuit 28 for communicating witha medical device 12, an input user interface 88, an output userinterface 90, memory 92 and a power supply 94. The circuit 28 forcommunicating with a medical device comprises inductive coils in oneembodiment and telemetry circuitry radio frequency telemetry circuitryin another embodiment. The input user interface 88 includes, but is notlimited to, a keyboard 96, a mouse 98, a light pen and a touch screen.Further, in one embodiment, the output user interface 90 includes, butis not limited to, printers and displays. In one embodiment, thegraphical display 32 is an electronic display such as a CRT monitor orLCD, for example, that forms an integral part of the programmer 14.However, the graphical display 32 is not so limited. In otherembodiments, the graphical display includes other means for graphicallydisplaying the configuration. These other means include, but are notlimited to, printing out the graphical display of the configuration on aprinter, and projecting the graphical display of the configuration on adevice in communication with the programmer 14 such as, for example, alocal peripheral device, a remote device, or a device networked to theprogrammer 14.

FIGS. 5 and 6 show that one embodiment of the graphical display 32 ofthe programmer device 14 includes both a lead representation 18, 20 and22 and an electrode representation 36, 38, 40, 46 and 48. In oneembodiment, the lead representation includes a lead positionrepresentation. The graphical display 32 has been shown and describedabove with respect to the system aspect 10 of the present invention andas such will not be reiterated here with respect to the programmerdevice 14.

FIG. 7 provides a flow chart for a software program 100 that provides aprogramming interface for an implantable medical device 12. The softwareprogram 100 is encoded in a computer-readable medium, i.e. the memory 92of the programmer 14, computer or other processor device for example.The illustrated software program 100 generally executes the following:at 102, receiving information about a configuration; and at 104,graphically displaying the configuration. As provided above, the leadconfiguration information for a medical device 12 includes but is notlimited to the quantity and physical arrangement of the leads 18, 20 and22, the quantity and physical arrangement of the electrodes 24, theelectrode type, the pulse polarity, and the electrical vectors betweenthe electrodes.

Receiving information about a configuration requires a data input 106for the configuration information. One embodiment of this step isillustrated at 108. The programmer 14 has a memory 92 that contains a“patient data” section. One means for receiving information about aconfiguration is to store this information in the programmer memory 92as part of the patient data, and then selectively retrieve thatinformation from the programmer memory 92. Thus, during the implant ofthe medical device, the doctor, clinical engineer or other user willenter lead identification and pacing site information for the implantedleads into the memory 92 of the programmer 14. Alternatively, at 110,this information is stored in the memory 80 of the medical device 12 andretrieved by any doctor or clinical engineer at any location usinganother programmer. The relevant information travels with the patientwithout being limited by the location of the patient's doctor or clinic,and the clinic's programmer. Another alternative is shown at 112; namelythat this information may be provided from a user who has reviewed themedical history of the patient. Although not shown in the figures, othermeans for inputting this information include magnetic and opticalscanners, whereby the information is appropriately encoded into a cardor other medium that is capable of being magnetically or opticallyscanned, or otherwise read.

In one embodiment, when the software program graphically displays theconfiguration at 104, the software program is graphically displaying oneor more of the following representations: a lead representation, anelectrode representation, a pulse polarity, and a vector. The displayand the representations incorporated therein have been discussed abovewith respect to the system 10 and as such will not be reiterated herewith respect to the software program. In other embodiments, the softwareprogram executes the following: at 114, receiving changed configurationinformation, such as through a user input when a user is programming theconfiguration; at 116, verifying that the changed setting is acceptable;and at 118, upon verifying that the changed settings are acceptable,accepting the changed settings and programming the configuration.

FIG. 8 provides a flow chart for a method aspect 120 of the presentsubject matter. The method 120 generally comprises the steps of: at 122,receiving configuration information for a medical device having at leastone lead with at least one electrode; and at 124, presenting a graphicalrepresentation of the configuration information on a display. In oneembodiment, at 126, the configuration information is retrieved from amemory, such as that stored in a patient data section of the programmer.Alternatively, at 128, this information is stored in the memory of themedical device and retrieved by any doctor or clinical engineer at anylocation using another programmer. Another alternative is that, at 130,this information is provided from a user who has reviewed the medicalhistory of the patient.

In another embodiment, the method further comprises at 132, programminga change in the configuration. As described above, this step isperformed by a user who is using a programmer to program or otherwiseconfigure the medical device. In this embodiment, presenting a graphicalrepresentation of the configuration includes presenting both currentsettings and changed settings for the medical device. A user reviewsboth the current and changed settings to determine whether the changesshould be programmed into the medical device.

In another embodiment, the step of presenting a graphical representationof the configuration information may include, but is not limited to,presenting one or more of the following graphical representations: anarrangement of the lead(s) in a heart, an electrode type, a pulsepolarity, and vectors.

A graphical display of the configuration has been discussed above indetail with respect to the system aspect of the present invention and assuch will not be reiterated here with respect to the method aspect ofthe present invention.

FIGS. 9-27 illustrate vectors for a lead configuration of a medicaldevice. The particular lead configuration, including the position of theleads, and the vectors or illustrated as examples of vectors, and do notprovide an exclusive list of available configurations.

FIGS. 9-14 illustrate pacing vector examples for a left ventricularlead. FIG. 9 shows a left ventricular pace from a ring electrode 46positioned on a left ventricular lead 22 to a coil electrode 40positioned on a right ventricular lead 20. FIG. 10 shows a leftventricular pace from two ring electrodes 46 and 48 positioned on a leftventricular lead 22 to a coil electrode 40 positioned on a rightventricular lead 20. FIG. 11 shows a left ventricular pace from two ringelectrodes 46 and 48 and a tip electrode 36 positioned on a leftventricular lead 22 to a coil electrode 40 positioned on a rightventricular lead 20. FIG. 12 shows a left ventricular pace from a tipelectrode 36 positioned on a left ventricular lead 22 to a coilelectrode 40 positioned on a right ventricular lead 20. FIG. 13 shows aleft ventricular pace from a tip electrode 36 to a ring electrode 46,both of which are positioned on a left ventricular lead 22. FIG. 14shows a left ventricular pace from a tip electrode 36 to two ringelectrodes 46 and 48, all of which are positioned on a left ventricularlead 22.

FIGS. 15-17 illustrate sensing vector examples for a left ventricularlead. FIG. 15 shows a left ventricular sense between a tip electrode 36positioned on a left ventricular lead 22 and a coil electrode 40positioned on a right ventricular lead 20. FIG. 16 shows a leftventricular sense between a tip electrode 36 a ring electrode 46, bothof which are positioned on a left ventricular lead 22. FIG. 16 shows aleft ventricular sense between a tip electrode 36, and two ringelectrodes 46 and 48, all of which are positioned on a left ventricularlead 22.

FIGS. 18-19 illustrate pacing vector examples for an atrial lead. FIG.18 shows an atrial pace from a tip electrode on an atrial lead 18 to thecan or medical device 12. FIG. 19 shows an atrial pace from a tipelectrode to a ring electrode, both of which are on an atrial lead 18.

FIGS. 20-21 illustrate sensing vector examples for an atrial lead. FIG.20 shows an atrial sense between a tip electrode on an atrial lead 18and the can or medical device. FIG. 21 shows an atrial sense between atip electrode and a ring electrode, both of which are on an atrial lead18.

FIGS. 22-23 illustrate defibrillation vector examples. FIG. 22 shows adefibrillation vector between a conductor 40 and the can or medicaldevice 12. FIG. 23 shows a defibrillation vector between a conductor 40and the coil inductor 38. Although defibrillation pulses have polarity,these illustrated defibrillation vectors do not show a polarity becauseof the nature of defibrillation vectors. The most common defibrillationtypes are biphasic which switch polarity half way through the shock, andmonophasic which have a fixed polarity that is programmable into thedevice from the programmer.

FIGS. 24-25 illustrate pacing vector examples for a right ventricularlead. FIG. 24 shows a right ventricular pace from a tip electrodepositioned on a right ventricular lead 20 to a can or medical device 12.FIG. 25 shows a right ventricular pace from a tip electrode to a ringelectrode 40, both positioned on a right ventricular lead 20.

FIGS. 26-27 illustrate sensing vector examples for a right ventricularlead. FIG. 26 shows a right ventricular sense between a tip electrodepositioned on a right ventricular lead 20 to a can or medical device.FIG. 27 shows a right ventricular sense between a tip electrode to aring electrode 40, both positioned on a right ventricular lead 20.

The present invention, as described above, is not limited to anyparticular chamber of the heart, or combination of chambers, but coversany lead placement inside or outside of the right and left atriums andventricles, and any vectors that can be formed between the electrode(s).

This application is intended to cover any adaptations or variations ofthe present invention. It is manifestly intended that this invention belimited only by the claims and equivalents thereof.

1. A device, comprising: a graphical display; and a machine-readablemedium comprising instructions, which when implemented by one or moreprocessors perform the following operations: communicating with animplantable medical device (IMD), wherein the IMD has at least oneelectrode; providing an image on the graphical display, includingproviding a representative image of a proposed electrical signal to beapplied by the IMD between the at least one electrode of the MD and atleast one other electrode before the IMD applies the electrical signalbetween the at least one electrode and the at least one other electrode;receiving user verification that that the proposed electrical signal isacceptable; and programming the IMD to deliver the proposed electricalsignal.
 2. The device of claim 1, wherein the representative imageincludes a representation of a pace vector.
 3. The device of claim 1,wherein the representative image includes a representation of a sensevector.
 4. The device of claim 1, wherein the representative imageincludes a representation of a defibrillation vector.
 5. The device ofclaim 1, wherein the representative image includes a color scheme torepresent elements of the at least one lead with the at least oneelectrode, and the programmable electrical configuration.
 6. Aprocessing device, comprising: a graphical display, wherein theprocessing device is adapted to be in communication with an implantablemedical device, the implantable medical device including at least onelead with at least one electrode, and wherein the processing device isadapted to provide an image on the graphical display, including arepresentative image of an electrical signal to be applied between theat least one electrode and at least one other electrode before theimplantable medical device applies the electrical signal between the atleast one electrode and the at least one other electrode.
 7. Theprocessing device of claim 6, wherein the representative image includesa representation of a pulse polarity for the programmable electricalconfiguration.
 8. The processing device of claim 6, wherein therepresentative image includes a representation of a vector associatedwith the at least one electrode that is indicative of at least one of asensing vector and a pulsing vector.
 9. The processing device of claim6, wherein the graphical display represents present settings for theprogrammable electrical configuration, and wherein the present settingsare stored in a memory.
 10. A system for providing a graphical displayof lead configuration for an implantable medical device having at leastone lead with at least one electrode in a programmable electricalconfiguration, the implantable medical device being adapted to apply anelectrical signal between the at least one electrode and at least oneother electrode of the implantable medical device based on theprogrammable electrical configuration, the system comprising: means forreceiving information about the lead configuration and the programmableelectrical configuration, wherein receiving information includesreceiving both a present setting and a proposed changed setting for theprogrammable electrical configuration; means for graphicallyrepresenting the lead configuration and the programmable electricalconfiguration as a representative image, including a representativeimage of the electrical signal to be applied between the at least oneelectrode and the at least one other electrode for the proposed changedsetting; means for receiving user verification that that the proposedchanged setting is acceptable; and means for accepting the changedsetting as the present setting for the programmable electricalconfiguration.
 11. The system of claim 10, wherein the means forgraphically representing the programmable electrical configurationincludes means for representing a lead position and an electrodeposition type in the representative image of the programmable electricalconfiguration for the at least one electrode.
 12. The system of claim10, wherein the means for graphically representing the programmableelectrical configuration includes means for representing a pulsepolarity type in the representative image of the programmable electricalconfiguration for the at least one electrode.
 13. The system of claim10, wherein the means for graphically representing the programmableelectrical configuration includes means for representing a vector typein the representative image of the programmable electrical configurationfor the at least one electrode.
 14. The system of claim 13, wherein themeans for representing the vector comprises means for representing apace vector type in the representative image of the programmableelectrical configuration for the at least one electrode.
 15. The systemof claim 13, wherein the means for representing the vector comprisesmeans for representing a sense vector type in the representative imageof the programmable electrical configuration for the at least oneelectrode.
 16. The system of claim 13, wherein the means forrepresenting the vector comprises means for representing adefibrillation vector type in the representative image of theprogrammable electrical configuration for the at least one electrode.17. A method for providing a graphical display of lead configuration foran implantable medical device having at least one lead with at least oneelectrode in a programmable electrical configuration, the implantablemedical device being adapted to apply an electrical signal between theat least one electrode and at least one other electrode of theimplantable medical device based on the programmable electricalconfiguration, the method comprising: receiving information about thelead configuration and the programmable electrical configuration,wherein receiving information includes receiving both a present settingand a proposed changed setting for the programmable electricalconfiguration; graphically representing the lead configuration and theprogrammable electrical configuration as a representative image,including a representative image of the electrical signal to be appliedbetween the at least one electrode and the at least one other electrodefor the proposed changed setting; receiving user verification that thatthe proposed changed setting is acceptable; and accepting the changedsetting as the present setting for the programmable electricalconfiguration.
 18. The method of claim 17, wherein graphicallyrepresenting the programmable electrical configuration includesgraphically displaying a lead representation and an electroderepresentation in the representative image.
 19. The method of claim 18,wherein graphically representing the programmable electricalconfiguration includes graphically displaying a pulse polarity in therepresentative image.
 20. The method of claim 18, wherein graphicallyrepresenting the programmable electrical configuration includesgraphically displaying a vector in the representative image.
 21. Themethod of claim 20, wherein the vector comprises a pace vector in therepresentative image.
 22. The method of claim 20, wherein the vectorcomprises a sense vector in the representative image.
 23. The method ofclaim 20, wherein the vector comprises a defibrillation vector in therepresentative image.